Instrument reprocessor and instrument reprocessing methods

ABSTRACT

An instrument reprocessor for cleaning, disinfecting, and/or sterilizing a medical instrument is disclosed. To reprocess instruments having one or more channels defined therein, the reprocessor can include one or more flow control systems configured to control a flow of fluid through each channel. In various embodiments, a flow control system can include a differential pressure sensor and a proportional valve for controlling the fluid flow in a channel. The reprocessor can also include, one, a fluid circulation pump which can be configured to supply the flow control systems with fluid and, two, a system for controlling the pressure of the fluid supplied to the flow control systems. The reprocessor can also include a system for supplying a metered amount of fluid to the fluid circulation system. The system can include a reservoir having a fluid height sensor to monitor the amount of fluid therein and a pump configured to supply the reservoir with fluid.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a divisional application claiming priorityunder 35 U.S.C. § 120 to co-pending U.S. patent application Ser. No.14/533,789 entitled “INSTRUMENT REPROCESSOR AND INSTRUMENT REPROCESSINGMETHODS” filed Nov. 5, 2014 which, in turn, is a divisional applicationclaiming priority under 35 U.S.C. § 120 to U.S. patent application Ser.No. 13/278,874, now U.S. Pat. No. 8,920,574 entitled “INSTRUMENTREPROCESSOR AND INSTRUMENT REPROCESSING METHODS,” filed Oct. 21, 2011,the entire disclosures of which applications are incorporated byreference herein in their entirety and for all purposes.

BACKGROUND i. Field of the Invention

The present invention generally relates to the reprocessing, cleaning,sterilizing, and/or decontamination of medical instruments.

ii. Description of the Related Art

In various circumstances, an endoscope can include an elongate portion,or tube, having a distal end which can be configured to be inserted intothe body of a patient and, in addition, a plurality of channelsextending through the elongate portion which can be configured to directwater, air, and/or any other suitable fluid into a surgical site. Insome circumstances, one or more channels in an endoscope can beconfigured to guide a surgical instrument into the surgical site. In anyevent, an endoscope can further include a proximal end having inlets influid communication with the channels and, in addition, a control headsection having one or more valves, and/or switches, configured tocontrol the flow of fluid through the channels. In at least onecircumstance, an endoscope can include an air channel, a water channel,and one or more valves within the control head configured to control theflow of air and water through the channels.

Decontamination systems can be used to reprocess previously-used medicaldevices, such as endoscopes, for example, such that the medical devicescan be used again. A variety of decontamination systems exist forreprocessing endoscopes. In general, such systems may include at leastone rinsing basin in which an endoscope that is to be cleaned and/ordisinfected can be placed. The rinsing basin is commonly supported by ahousing that supports a circulation system of lines, pumps and valvesfor the purpose of directing a cleaning and/or disinfecting agent intoand/or onto an endoscope which has been placed in the basin. During thedecontamination process, the channels within the endoscope can beevaluated in order to verify that the channels are unobstructed. Invarious embodiments, the circulation system can be fluidly coupled tothe endoscope channels by connectors which releasably engage ports whichcan define the ends of the channels. Such connectors can achieve afluid-tight seal while attached to the endoscope, yet they can be easilyreleasable at the conclusion of the decontamination process.

The foregoing discussion should not be taken as a disavowal of claimscope.

SUMMARY

In at least one form, an instrument reprocessor for cleaning a medicalinstrument can comprise a chamber configured to receive the medicalinstrument, a supply of reprocessing fluid, a supply pump in fluidcommunication with the supply of reprocessing fluid, wherein the supplypump comprises a positive-displacement pump, and a reservoir in fluidcommunication with the supply pump, wherein the reservoir comprises atop and a bottom, and wherein the reservoir can comprise a reprocessingfluid height between the top and the bottom. The instrument reprocessorcan further comprise a linear sensor extending between the reservoir topand the reservoir bottom, wherein the linear sensor is configured todetect the reprocessing fluid height and, in addition, a processor insignal communication with the linear sensor, wherein the processor isconfigured to operate the supply pump when the reprocessing fluid heightis below a predetermined height, and wherein the predetermined height isbetween the reservoir top and the reservoir bottom. The instrumentreprocessor can further comprise a dispensing pump in fluidcommunication with the reservoir bottom and the chamber, wherein thedispensing pump comprises a positive-displacement pump, and wherein theprocessor is configured to operate the dispensing pump.

In at least one form, a method of controlling the flow of reprocessingfluid through an instrument having at least a first channel and a secondchannel can comprise the steps of operating a pump in fluidcommunication with a reprocessing fluid source, flowing the reprocessingfluid through a first fluid circuit comprising a first valve and a firstpressure differential sensor, wherein the first fluid circuit is influid communication with the pump and the first channel, and flowing thereprocessing fluid through a second fluid circuit comprising a secondvalve and a second pressure differential sensor, wherein the secondfluid circuit is in fluid communication with the pump and the secondchannel. The method can further comprise the steps of detecting a firstpressure differential in the reprocessing fluid flowing into the firstvalve utilizing the first pressure differential sensor, detecting asecond pressure differential in the reprocessing fluid flowing into thesecond valve utilizing the second pressure differential sensor,modulating the first valve to control the first flow rate ofreprocessing fluid through the first channel utilizing an output fromthe first pressure differential sensor, and modulating the second valveto control the second flow rate of reprocessing fluid through the secondchannel utilizing an output from the second pressure differentialsensor.

In at least one form, an instrument reprocessor for cleaning a medicalinstrument including a passage can comprise a chamber configured toreceive the medical instrument, a supply connector configured to befluidly coupled with the passage, a pump configured to pressurize areprocessing fluid and supply the reprocessing fluid to the supplyconnector, the pump comprising an inlet and an outlet, and a gaugepressure sensor positioned to sense the gauge pressure of thereprocessing fluid flowing from the pump outlet. The instrumentreprocessor can further comprise a flow control system including a valvein fluid communication with the supply connector, wherein the valve isconfigured to control a flow rate of reprocessing fluid through thepassage, and wherein the valve comprises an inlet and an outlet. Theinstrument reprocessor can further include a pressure differentialsensor configured to sense a pressure drop in the reprocessing fluid onopposite sides of a fixed orifice, wherein the pressure differentialsensor is positioned downstream with respect to the gauge pressuresensor and upstream with respect to the valve outlet, and a processor insignal communication with the pressure differential sensor, wherein theprocessor is configured to interpret the flow rate based on the pressuredrop and command the valve to at least one of at least partially closeand at least partially open.

In at least one form, a method of utilizing a monitoring system formaintaining a volume of reprocessing fluid within a supply reservoir fora fluid circulation system of an instrument reprocessor can comprise thesteps of supplying a quantity of reprocessing fluid to the supplyreservoir from a reprocessing fluid source, sensing the quantity ofreprocessing fluid in the supply reservoir, and determining whether thequantity of reprocessing fluid in the supply reservoir is more than apredetermined amount. The method can further comprise the steps ofoperating a positive-displacement filling pump to supply reprocessingfluid to the supply reservoir if the quantity of reprocessing fluid inthe supply reservoir is less than the predetermined amount, wherein thepositive-displacement filling pump is configured to supply a fixedvolume of reprocessing fluid per stroke, monitoring the quantity ofreprocessing fluid in the supply reservoir as the positive-displacementfilling pump is being operated, determining whether the quantity ofreprocessing fluid in the supply reservoir has increased by a re-supplyvolume equal to the product of the volume displaced per stroke and thenumber of strokes of the positive-displacement filling pump, andbroadcasting an alert if the quantity of reprocessing fluid in thesupply reservoir has not increased by the re-supply volume.

In at least one form, a method of controlling the flow of reprocessingfluid through an instrument comprising a channel can comprise the stepsof operating a pump in fluid communication with a reprocessing fluidsource, measuring the gauge pressure of the reprocessing fluid flowingfrom the pump, adjusting the flow of the reprocessing fluid to adjustthe gauge pressure of the reprocessing fluid, and flowing thereprocessing fluid through a fluid circuit comprising a valve and apressure differential sensor, wherein the fluid circuit is in fluidcommunication with the pump and the channel. The method can furthercomprise the steps of detecting a pressure differential in thereprocessing fluid flowing into the valve utilizing the pressuredifferential sensor, and modulating the valve to control the flow rateof reprocessing fluid through the channel utilizing an output from thepressure differential sensor.

In at least one form, a method of controlling the flow of reprocessingfluid through an instrument having at least a first channel and a secondchannel, wherein the first channel is defined by a first value of aparameter and the second channel is defined by a second value of theparameter, can comprise the steps of initializing a pump in fluidcommunication with a reprocessing fluid source to begin an operatingcycle, supplying the reprocessing fluid to a first fluid circuitcomprising a first valve, wherein the first fluid circuit is in fluidcommunication with the pump and the first channel, and supplying thereprocessing fluid to a second fluid circuit comprising a second valve,wherein the second fluid circuit is in fluid communication with the pumpand the second channel. The method can further comprise the step ofmodulating the first valve to limit the flow of reprocessing fluidthrough the first channel, wherein the flow of reprocessing fluid islimited by an amount based on the difference between the first value ofthe parameter and the second value of the parameter, whereby thereprocessing fluid flows through the first channel and the secondchannel when the pump is initialized.

The foregoing discussion should not be taken as a disavowal of claimscope.

DESCRIPTION OF THE DRAWINGS

The features and advantages of this invention, and the manner ofattaining them, will become more apparent and the invention itself willbe better understood by reference to the following description ofembodiments of the invention taken in conjunction with the accompanyingdrawings, wherein:

FIG. 1 is a perspective view of an endoscope reprocessor in accordancewith at least one embodiment comprising two basins;

FIG. 2 is a perspective view of the basins of the endoscope reprocessorof FIG. 1;

FIG. 3 is a diagram of a channel flow subsystem of the endoscopereprocessor of FIG. 1;

FIG. 3A is a diagram of a channel flow subsystem for controlling thepressure of the fluid flowing therethrough;

FIG. 4 is a perspective view of a manifold assembly including aplurality of flow control units;

FIG. 5 is a perspective view of the manifold of the manifold assembly ofFIG. 4;

FIG. 6 is a perspective view of a flow control unit configured tocontrol the flow of fluid through an endoscope channel supply line;

FIG. 7 is a perspective view of a proportional valve of the flow controlunit of FIG. 6;

FIG. 8 is a perspective view of the flow control unit of FIG. 6 with theproportional valve of FIG. 7 removed;

FIG. 9 is a perspective view of a subassembly of the control unit ofFIG. 6 including a printed circuit board (PCB) assembly, a gaugepressure sensor, and two differential pressure sensors;

FIG. 10 is a perspective view of the differential pressure sensor of thecontrol unit of FIG. 9.

FIG. 11 is a perspective view of the gauge pressure sensor of thecontrol unit of FIG. 9;

FIG. 12 is a perspective view of a fluid delivery system;

FIG. 13 is a top view of the fluid delivery system of FIG. 12;

FIG. 14 is a cross-sectional elevational view of the fluid deliverysystem of FIG. 12;

FIG. 15 is an elevational view of the fluid delivery system of FIG. 12;

FIG. 16 is a schematic of the fluid delivery system of FIG. 12; and

FIG. 17 illustrates an endoscope positioned within an endoscope carrierin the basin of FIG. 2.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate certain embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those of ordinary skill in the art will understand that thedevices and methods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the various embodiments of the present invention is definedsolely by the claims. The features illustrated or described inconnection with one exemplary embodiment may be combined with thefeatures of other embodiments. Such modifications and variations areintended to be included within the scope of the present invention.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment”, or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment”, or “in an embodiment”, or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation. Such modifications and variations are intended to beincluded within the scope of the present invention.

The terms “proximal” and “distal” are used herein with reference to asurgical instrument. The term “proximal” referring to the portionclosest to the clinician and the term “distal” referring to the portionlocated away from the clinician. It will be further appreciated that,for convenience and clarity, spatial terms such as “vertical”,“horizontal”, “up”, and “down” may be used herein with respect to thedrawings. However, in some circumstances, the devices disclosed hereinmay be used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

As described above, referring to FIG. 1, a medical instrumentreprocessor, such as endoscope reprocessor 100, for example, can beconfigured to clean one or more endoscopes. In certain embodiments, theendoscope reprocessor can be configured to disinfect and/or sterilize anendoscope. In various embodiments, the endoscope reprocessor cancomprise at least one basin 110, wherein each basin 110 can beconfigured to receive an endoscope therein. Although the endoscopereprocessor 100 comprises two basins, for example, various alternativeembodiments are envisioned which comprise any suitable number of basins110. In various embodiments, the reprocessor 100 can further include oneor more endoscope carriers 120 configured to support an endoscopetherein which can be placed in each basin 110. In use, a clinician canplace the endoscope into the endoscope carrier 120 and then position theendoscope carrier 120 within the basin 110. Alternatively, the cliniciancan position the carrier 120 in the basin 110 and then position theendoscope in the carrier 120. In either event, once the endoscope hasbeen suitably positioned within the basin 110, a folding door 130 can beclosed, secured and/or sealed to the reprocessor frame 140 in order toenclose the endoscope within the basin 110. Thereafter, the cliniciancan operate the endoscope reprocessor 100 by interfacing with a controlpanel 150, for example. Exemplary embodiments of the basin 110, thecarrier 120, and the folding door 130 are described in acontemporaneously-filed, co-owned United States patent applicationentitled INSTRUMENT REPROCESSORS, SYSTEMS, AND METHODS, the entiredisclosure of which is incorporated by reference herein. Referring nowto FIG. 17, an endoscope 101 is illustrated as being positioned within acarrier 120 which is positioned in a basin 110. In various embodiments,the endoscope 101 can comprise various portions 102, 103, and/or 104which can be supported within the carrier 120.

In various embodiments, further to the above, the endoscope reprocessor100 can include a circulation system which can circulate one or morereprocessing fluids such as detergent, sterilant, disinfectant, water,alcohol, and/or any other suitable fluid, for example, through theendoscope and/or spray the fluid onto the endoscope. The circulationsystem can comprise a fluid supply and a circulation pump, wherein thecirculation pump can be fluidly connected to the fluid supply such thatthe fluid can be drawn from the fluid supply into the circulationsystem. In certain embodiments, the circulation system can include amixing chamber in which the fluid can be mixed with another fluid, suchas water, for example, wherein the mixing chamber can be in fluidcommunication with the circulation pump. In either event, referring nowto FIG. 2, each basin 110 can comprise one or more spray nozzles 112which can be in fluid communication with the circulation pump such thatthe fluid pressurized by the circulation pump can be ejected from thecirculation system through the nozzles 112 and onto the endoscope. In atleast one such embodiment, each basin 110 can include a plurality ofnozzles 112 positioned around the perimeter thereof and one or morenozzles 112 which can spray upwardly from the basin floor, orbacksplash, 111. Certain exemplary embodiments are described in greaterdetail in a contemporaneously-filed, co-owned United States patentapplication entitled INSTRUMENT REPROCESSORS, SYSTEMS, AND METHODS, theentire disclosure of which is incorporated by reference herein.

In various embodiments, further to the above, each basin 110 can beconfigured to guide the fluid sprayed therein downwardly toward a drain116 positioned at the bottom thereof wherein the fluid can then re-enterthe circulation system. In order to clean, disinfect, and/or sterilizeinternal channels within the endoscope, the endoscope reprocessor 100can include one or more supply lines in fluid communication with thecirculation system pump which can be placed in fluid communication withthe internal channels of the endoscope. In various embodiments,referring again to FIG. 2, each basin 110 can include one or more ports114 which can comprise the ends of the supply lines. In the illustratedembodiment, each basin 110 has a bank of four ports 114 positioned onopposite sides thereof, although other alternative embodiments areenvisioned which can comprise any suitable number and arrangement ofports 114. In certain embodiments, the endoscope reprocessor 110 canfurther comprise one or more flexible conduits which can be connectedand/or sealingly engaged with the ports 114 and the channels defined inthe endoscope such that the pressurized fluid from the circulationsystem can flow through the ports 114, the flexible conduits, and theninto the endoscope. Flexible conduits and the connectors used tosealingly engage the flexible conduits to the endoscope are described inU.S. patent application Ser. No. 12/998,459, entitled FLUID CONNECTORFOR ENDOSCOPE REPROCESSING SYSTEM, which was filed on Aug. 29, 2011 andU.S. patent application Ser. No. 12/998,458, entitled QUICK DISCONNECTFLUID CONNECTOR, which was also filed on Aug. 29, 2011, the entiredisclosures of which are incorporated by reference herein.

In various circumstances, further to the above, the channels definedwithin the endoscope can be become blocked or obstructed by debris, forexample, which can inhibit the endoscope from being properly cleaned,disinfected, and/or sterilized. In some circumstances, the debrispositioned within an endoscope channel can at least partially block theflow of the fluid therethrough thereby reducing the rate in which thefluid can flow through the channel. Various embodiments of an endoscopereprocessor are envisioned herein in which the flow rate of the fluidthrough an endoscope channel can be monitored to evaluate whether anobstruction exists in the channel. In such embodiments, the monitoringsystem could measure the actual flow rate of the fluid and compare it toflow rate of the fluid which would be expected given the pressure inwhich the fluid was pressurized to by the circulation pump. Certainmonitoring systems could also evaluate whether the connectors of theflexible conduit are sealingly engaged with the endoscope channel and/orthe basin ports 114, for example. In such systems, the monitoring systemcould detect whether the flow rate of the fluid is above an expectedflow rate, for example. The entire disclosure of U.S. Pat. No.7,879,289, entitled AUTOMATED ENDOSCOPE REPROCESSOR SELF-DISINFECTIONCONNECTION, which issued on Feb. 1, 2011, is incorporated by referenceherein.

Referring now to the diagram of FIG. 3, an endoscope reprocessor cancomprise a channel flow subsystem 160 including a manifold 166 in fluidcommunication with the circulation system pump, indicated as pump 162,which can be configured to distribute the pressurized fluid to thechannel supply lines of the endoscope reprocessor and then to thechannels of the endoscope. Such channel supply lines of the endoscopereprocessor are indicated as supply lines 164 in the diagram of FIG. 3.In various embodiments, each endoscope reprocessor supply line 164 caninclude at least one differential pressure sensor 172, at least oneproportional valve 174, and at least one gage pressure sensor 176. Incertain embodiments, referring now to FIGS. 6 and 9, each reprocessorchannel supply line 164 can include a control unit assembly 170comprising a housing 171, a differential pressure sensor 172, aproportional valve 174, and a gage pressure sensor 176. In at least onesuch embodiment, each housing 171 can include an inlet 168 and aninternal passage which can be configured to direct the flow of fluidthrough an inlet 173 a and then an outlet 173 b of the differentialpressure sensor 172. Between the inlet 173 a and the outlet 173 b of thedifferential pressure sensor 172 an orifice 175 (FIG. 10) can be definedwhich comprises a fixed diameter. In at least one such embodiment, thediameter of the orifice 175 can be constant along the length thereof.Such an orifice could be created by a drilling process, for example. Invarious other embodiments, the diameter of the orifice 175 may not beconstant along the length thereof. In either circumstance, such orificescan be fixed in the sense that they do not change, or at leastsubstantially change, over time. As described in greater detail below,referring now to FIGS. 9 and 10, the differential pressure sensor 172can further comprise a plurality of electrical contacts 177 which canplace the differential pressure sensor 172 in signal communication witha printed circuit board (PCB) assembly 179 of the control unit assembly170. The electrical contacts 177 can also be configured to supply thedifferential pressure sensor 172 with electrical power. Various pressuredifferential sensors are commercially available from Honeywell, forexample.

As outlined above, the differential pressure sensor 172 can be inelectrical and/or signal communication with the PCB assembly 179. Morespecifically, the PCB assembly 179 can include, among other things, amicroprocessor and/or any suitable computer, for example, wherein thedifferential pressure sensor 172 can be configured to generate a voltagepotential which is communicated to the microprocessor of the PCBassembly 179. In at least one such embodiment, the microprocessor of thePCB assembly 179 can be configured to interpret the voltage potentialsupplied by the differential pressure sensor 172 and calculate the flowrate of the fluid flowing through the differential pressure sensor 172.

In certain embodiments, further to the above, a plurality of fluid flowrate values can be stored in a look-up table defined within programmablememory on the PCB assembly 179, for example. Oftentimes, in variousembodiments, the values of the expected fluid flow rates in the look-uptable can be theoretically predicted while, in certain embodiments, thevalues can be empirically tested and then stored in the programmablememory. In either event, the fluid flow rate can be determined as afunction of the gauge pressure of the fluid being discharged by thecirculation pump 162 and supplied to the manifold 166. In at least onesuch embodiment, a gauge pressure sensor, such as gauge pressure sensor159 (FIG. 3), for example, can be positioned downstream with respect tothe outlet of the circulation pump 162 such that the gauge pressure ofthe fluid being supplied to each of the reprocessor channel supply lines164 can be measured. In such embodiments, the gauge pressure sensor 159can be placed in electrical and/or signal communication with each PCBassembly 179 of the flow control units 170 such that the gauge pressureof the fluid can be communicated to the microprocessor of each PCBassembly 179 in the form of a voltage potential. Once the gauge pressureof the fluid has been communicated to the PCB assembly 179, in variousembodiments, the microprocessor can derive the fluid flow rate of thefluid from the look-up table and compare the fluid flow rate value tothe target fluid flow rate. Oftentimes, the actual flow rate will notexactly match the target flow rate and, thus, a range of values for theactual flow rate between a minimum target value and a maximum targetvalue may be acceptable.

In various embodiments, further to the above, the fluid flow ratethrough an reprocessor channel supply line 164 can be determined as afunction of two variables, the gauge pressure reading from the gaugepressure sensor 159, as described above, and, in addition, the pressuredifferential reading from the differential pressure sensor 172 of acorresponding flow control unit 170. Such a system may utilize aplurality of look-up tables to derive the flow rate of the fluid. Forinstance, for every potential gauge pressure of the fluid that may besupplied to the manifold 166, such as 35 psi, for example, a tablecorrelating the reading of the differential pressure sensor 172 and theexpected flow rate could be stored within each PCB assembly 179. In suchembodiments, a large range of gauge pressures may need to be accountedfor and, thus, a large number of look-up tables may be needed. Invarious other embodiments, the pressure of the fluid being supplied tothe reprocessor supply lines 164 may be limited to a particular pressureor a limited range of pressures. In at least one such embodiment,referring to FIG. 3A, the fluid circulation system of the instrumentreprocessor 100 can include a pressure limiting valve, such as aproportional valve 158, for example, which can be in fluid communicationwith the outlet of the circulation pump 162 and a fluid feedback loop157. In at least one such embodiment, the proportional valve 158 can beconfigured to redirect a portion the fluid being discharged by the pump162 and return the redirected fluid to the circulation system at aninlet positioned upstream with respect to the pump 162, for example,such that the pressure of the fluid being supplied to the manifold 166is provided at a constant, or an at least substantially constantpressure, such as 35 psig, for example. In at least one such embodiment,a PCB assembly including a microprocessor and/or any suitable computer,for example, can be utilized which is in electrical and/or signalcommunication with the gauge pressure sensor 159 and the proportionalvalve 158. In use, when the gauge pressure of the fluid is above 35psig, for example, the PCB assembly can command the proportional valve158 to open a certain amount, or an additional amount, to permit fluid,or more fluid, to flow through the fluid feedback loop 157. In suchcircumstances, such actions may lower the pressure of the fluid flowingto the manifold 166. In the event that the pressure of the fluid remainsgreater than 35 psig, the PCB assembly could command the proportionalvalve 158 to open an additional amount. Such steps could be repeated anysuitable number of times to arrive at the desired pressure of the fluid.Correspondingly, when the gauge pressure of the fluid is below 35 psig,for example, the PCB assembly can command the proportional valve 158 toclose a certain amount to reduce the rate of fluid flowing through thefluid feedback loop 157. In such circumstances, such actions may raisethe pressure of the fluid flowing to the manifold 166. In the event thatthe pressure of the fluid remains lower than 35 psig, the PCB assemblycould command the proportional valve 158 to close an additional amount.Such steps could be repeated any suitable number of times to arrive atthe desired pressure of the fluid.

In view of the above, in various embodiments, the gauge pressure of thefluid being supplied to the flow control units 170 of the reprocessorsupply lines 164 can be controlled such that it is maintained at aconstant, or an at least substantially constant, pressure. Accordingly,one of the variables for calculating the flow rate of the fluid flowingthrough the reprocessor supply lines 164 can be held constant, or atleast substantially constant. Thus, as a result, the flow rate of thefluid through each reprocessor supply line 164 and its associatedcontrol unit 170 may be a function of only one variable, i.e., thereading from the differential pressure sensor 172. In at least one suchembodiment, only one look-up table may be needed to calculate theactual, calculated flow rate and/or correlate the actual, calculatedflow rate with the target flow rate to determine whether the actual,calculated flow rate is between minimum and maximum acceptable valuesfor the fluid flow rate through a reprocessor supply line 164.

In the event that the actual fluid flow rate is between minimum andmaximum acceptable values for a given endoscope channel, as suppliedthereto by a reprocessor supply line 164, the PCB assembly 179 of thecorresponding flow control unit 170 may not adjust the proportionalvalve 174 and, instead, may continue to monitor the flow rate of thefluid flowing through the flow control unit 170. In the event that theactual flow rate of the fluid through the reprocessor supply line 164 isbelow the minimum acceptable value or above the maximum acceptable valuestored in the look-up table for a given gauge pressure for a givenreprocessor supply line 164, the PCB assembly 179 may open, partiallyopen, close, and/or partially close the proportional valve 174associated therewith. In at least one embodiment, referring to FIGS.6-8, the proportional valve 174 can comprise an orifice or chamber 180,a valve element positioned within the chamber 180, and a solenoid whichcan be activated to rotate the element within the chamber 180 between anopen position in which fluid can flow through the chamber, a closedposition in which the element obstructs the flow of fluid therethrough,and/or any other suitable position inbetween.

In various embodiments, further to the above, the microprocessor of thePCB assembly 179 can be configured to adjust the position of the valveelement within the valve chamber 180 of the proportional valve 174. Inuse, if the actual fluid flow rate through an reprocessor supply line164 is higher than the target fluid flow rate, the solenoid of theproportional valve 174 can move the valve element toward its closedposition to further constrict the flow of fluid therethrough. Likewise,if the actual fluid flow rate through the reprocessor supply line 164 islower than the target fluid flow rate, the solenoid of the proportionalvalve 174 can move the valve element toward its open position to reducethe constriction to the fluid flowing therethrough. In variousembodiments, the valve element can be rotated from an open position to afirst position to constrict a valve orifice a first amount, such asapproximately 25%, for example, to a second position to constrict thevalve orifice a second amount, such as approximately 50%, for example,to a third position to constrict the valve orifice a third amount, suchas approximately 75%, for example, and to a closed position in which thevalve orifice is approximately 100% constricted, for example. In variousembodiments, the valve element of the proportional valve 174 can bepositionable in any suitable number of positions to provide a desiredconstriction to the flow of fluid through the valve 174. In any event,the position of the valve element can be controlled by a voltagepotential applied to the valve solenoid by the PCB assembly 179 wherein,for example, a lower voltage potential applied to the valve solenoid canresult in the valve element being oriented in a position which is closerto its fully-closed position as compared to when a higher voltagepotential is applied to the valve solenoid which orients the valveelement in a position which is closer to its fully-open position, forexample.

In various circumstances, as a result of the above, the PCB assembly 179can be configured to continuously monitor the flow rate of the fluidflowing through a reprocessor supply line 164 and adjust theproportional valve 174 to increase and/or reduce the rate of fluidflowing through the reprocessor supply line 164 and, correspondingly,the endoscope channel fluidly coupled thereto. In various embodiments,further to the above, the PCB assembly 179 can be configured to keep theflow rate of the fluid at and/or near a desired flow rate. Inembodiments where the fluid being circulated is a sterilant or asolution including a sterilant, for example, the sterilant can sterilizethe endoscope; however, the sterilant may also negatively affect ordegrade the endoscope. Thus, in view of the above, the channel flowsubsystem 160 can be configured to supply a sufficient minimum flow ofsterilant to the endoscope in order to sterilize the endoscope yet limitthe maximum flow of sterilant to the endoscope such that the sterilantdoes not overly degrade the endoscope. Similarly, in view of the above,the channel flow subsystem 160 can be configured to supply a sufficientminimum flow of disinfectant to the endoscope in order to disinfect theendoscope yet limit the maximum flow of disinfectant to the endoscopesuch that the disinfectant does not overly degrade the endoscope. Invarious embodiments, each endoscope channel supply line can furtherinclude a second differential pressure sensor, such as differentialpressure sensor 178, for example, which can also detect the flow rate ofthe fluid through the reprocessor supply line 164. In at least one suchembodiment, the first differential pressure sensor 172 and the seconddifferential pressure sensor 178 of a control unit assembly 170 can beplaced in parallel with one another wherein, in the event that thepressure sensors 172 and 178 supply appreciably different voltagereadings to the PCB assembly 179, the PCB assembly 179 can execute acorrective action routine which could include closing the proportioningvalve 174, for example, and/or issuing an alert or warning to theoperator that the control unit assembly 170 may need to be serviced.

As outlined above, each proportional valve 174 can be configured tocontrol the condition of a variable orifice. In at least one suchembodiment, each proportional valve 174 can comprise a biasing element,such as a spring, for example, which can be configured to bias the valveelement of the proportional valve 174, discussed above, into anormally-closed condition. The solenoid of the proportional valve 174,as also discussed above, can be actuated to move the valve element intoan at least partially open position. In at least one embodiment, aseries of voltage pulses can be applied to the solenoid from thecorresponding PCB assembly 179 which can control the degree, or amount,in which the valve element is opened. In at least one such embodiment,the greater frequency in which the voltage pulses are applied to thesolenoid, the larger the variable orifice can be thereby permitting alarger flow rate of fluid therethrough. Correspondingly, the lowerfrequency in which the voltage pulses are applied to the solenoid, thesmaller the variable orifice can be thereby permitting a smaller flowrate of fluid therethrough. If the voltage pulses are no longer appliedto the solenoid of the proportional valve 174, the biasing element canmove the valve element into a closed condition once again. Other variousembodiments are envisioned in which the valve element is biased into anormally-open condition and the solenoid of the proportional valve canact to bias the valve element into an at least partially closedcondition. In various other embodiments, a valve for controlling theorifice can be configured to cycle a valve element between a fully openposition and a fully closed position and control the rate of fluidflowing therethrough by controlling the time in which the valve elementis closed as compared to the time in which the valve element is open. Inat least one such embodiment, the valve element can be cycled rapidlybetween its open and closed conditions by a solenoid, for example.

Further to the above, each reprocessor supply line 164 can include acontrol unit assembly 170 wherein the control unit assemblies 170 can beconfigured to control the flow of fluid through the reprocessor supplylines 164 independently of another. In various embodiments, the controlunit assemblies 170 may not be in electrical and/or signal communicationwith each other. In such embodiments, each control unit assembly 170 isconfigured to monitor and adjust the flow rate of the fluid flowingthrough a reprocessor supply line 164 without communicating with theother control unit assemblies 170. In various other embodiments,however, the control unit assemblies 170 can be in electrical and/orsignal communication with each other such that certain parameters of thefluid within the reprocessor supply lines 164 could be compared to oneanother, for example. In either event, the PCB assembly 179 of a controlunit 170 can be programmed to fully open the proportional valve 174thereof in the event that the gauge pressure exiting the control unit170 exceeds a predetermined maximum pressure, such as approximately21.75 psig, for example. In various embodiments, the gauge pressuresensor 176 of a control unit assembly 170, mentioned above, can beconfigured to, one, detect the gauge pressure of the fluid exiting theproportional valve 174 of a reprocessor supply line 164 and, two,communicate a voltage potential to its respective PCB assembly 179 whichcan interpret the voltage potential into a gauge pressure. As comparedto the differential pressure sensors 172 and 178 which can detect apressure drop in the fluid between two points in a fluid supply line,the gauge pressure sensors 176 can detect the actual pressure of thefluid, or gauge pressure. In various embodiments, referring to FIGS. 9and 11, a gauge pressure sensor 176 can comprise a passage 185 which canbe configured to direct the flow of fluid past a sensing element and toan outlet 183 of the flow control unit 170. Similar to the above, eachgauge pressure sensor 176 can comprise a plurality of electricalcontacts 187 which can place the gauge pressure sensor 176 in electricaland/or signal communication with its corresponding PCB assembly 179.

Further to the above, the manifold 166 of the fluid circulation system160 can be configured to distribute the fluid flowing therethrough toeight endoscope reprocessor supply lines 164 and the endoscope channelsassociated therewith. Referring now to FIG. 5, the manifold 166 caninclude an inlet 161, eight outlets 163, and a second inlet 165positioned on an opposite end of the manifold 166. In variousembodiments, the manifold 166 can be configured to receive anddistribute several different fluids throughout the operation of theendoscope reprocessor 100. Referring to FIG. 3 once again, the inlet 161of the manifold 166 can be configured to receive a flow of solutioncomprising water and detergent, among other things, from pump 162. Invarious embodiments, one or more valves can be operated to place thepump 162 in fluid communication with a source of water such that thepump 162 can pump water into the supply lines 164. In certainembodiments, one or more valves can be operated to place the pump 162 influid communication with a source of sterilant, or sterilant solution,such that the pump 162 can pump the sterilant into the supply lines 164.In at least one embodiment, referring again to FIG. 5, the endoscopereprocessor 100 can comprise one or more valves, such as valve 167, forexample, which can be operated to permit a flow of pressurized air froma pressurized air source 190, for example, into the manifold 166. In atleast one such embodiment, the pressurized air can force any remainingwater, detergent, and/or sterilant out of the endoscope channels. Incertain embodiments, the endoscope reprocessor 100 can further comprisea supply of alcohol 191 and a pump which can be configured to drawalcohol from the alcohol supply 191 and introduce the alcohol into themanifold 166 through the second inlet 165, for example. In at least onesuch embodiment, a check valve 192 can be positioned intermediate such apump and the second inlet 165 such that other fluids from the manifold166 cannot flow into the alcohol supply 191.

In view of the above, an instrument reprocessor can be configured tosupply one or more pressurized fluids to the channels of an instrument,such as an endoscope, for example. In various embodiments, the flowrates of the fluids being supplied to the endoscope channels can bemonitored. In the event that the flow rate of the fluid being suppliedto an endoscope channel is below a target flow rate or a minimumacceptable flow rate, the instrument reprocessor can increase the flowrate of the fluid flowing therethrough. In the event that the flow rateof the fluid being supplied to an endoscope channel is above a targetflow rate or a maximum acceptable flow rate, the instrument reprocessorcan decrease the flow rate flow of the fluid flowing therethrough. Incertain embodiments, the instrument reprocessor can include a pluralityof supply lines supplying the endoscope channels with fluid wherein eachsupply line can include a variable valve orifice which can be modulatedto adjust the flow rate of the fluid passing therethrough. In variousembodiments, the variable valve orifice of each supply line can be partof a closed loop arrangement which includes a fixed orifice pressuredifferential sensor configured to sense the flow rate of the fluid. Invarious embodiments, the pressure differential sensor can be positionedupstream with respect to the variable valve orifice and downstream withrespect to a circulation pump. In at least one embodiment, theinstrument reprocessor can further include a gauge pressure sensor forsensing the gauge pressure of the fluid exiting the circulation pump anda pressure control system which can be configured to modulate thepressure of the fluid relative to a targeted pressure. In at least onesuch embodiment, the differential pressure sensor can be positioneddownstream with respect to the gauge pressure sensor and the pressurecontrol system.

As described above, the fluid circulation system of the endoscopereprocessor 100 can be configured to circulate a fluid through anendoscope and/or spray the fluid onto the outside surface of theendoscope. In various embodiments, referring now to FIG. 8, theendoscope reprocessor 100 can comprise a fluid dispensing system 200which can be configured to dispense one or more fluids to the fluidcirculation system. In various embodiments, referring now to FIGS.12-16, the fluid dispensing system 200 can comprise two or more separatefluid dispensing subsystems, such as fluid dispensing subsystems 200 aand 200 b, for example, which can each be configured to dispense adifferent fluid, for example, to the fluid circulation system. Invarious embodiments, referring now to FIG. 16, the endoscope reprocessor100 can include a storage area which can be configured to house one ormore containers of a fluid, such as sterilant container 201 a and/ordetergent container 201 b, for example, therein wherein the endoscopereprocessor 100 can further include one or more fluid connectors whichcan each be sealingly engaged with one of the fluid containers. Incertain embodiments, the endoscope reprocessor 100 can further comprisea RFID reader and/or a bar code reader which can be configured to read aRFID tag and/or a bar code on the fluid container to ensure that, one,the correct fluid is being used and, two, that the fluid is being usedby a certain expiration date, for example. In any event, once the fluidconnector has been coupled to the fluid container, the fluid dispensingsystem 200 can be configured to draw the fluid from the fluid containerand dispense it into the circulation system, as described in greaterdetail further below.

In various embodiments, further to the above, the fluid subsystem 200 acan include a supply pump 210, a reservoir 220, and a dispensing pump230. In certain embodiments, the supply pump 210 can include an inlet211 in fluid communication with the fluid container and/or any othersuitable fluid source. In at least one embodiment, the supply pump 210can comprise a positive displacement pump which, in at least one suchembodiment, can comprise a piston configured to displace a fixed amountof volume, or fluid, per stroke of the piston. More specifically,referring primarily to FIG. 14, the supply pump 210 can comprise apiston 212 which can be configured to move, or reciprocate, within acylinder 213 between a first, or bottom dead center (BDC) position, anda second, or top dead center (TDC) position, in order to draw fluid intothe cylinder 213 and push the fluid through cylinder outlet 214. Incertain embodiments, the supply pump 210 can further comprise a valvelifter 215 which can be contacted by the piston 212 to open a valveelement and allow the fluid to exit through the pump outlet 214 when thepiston 212 reaches its TDC position. When the piston 212 is returned toits BDC position, a valve spring positioned behind the valve lifter 215,for example, can be configured to return the valve element and the valvelifter 215 to a seated position in which the outlet 214 is sealinglyclosed until the valve element and the valve lifter 215 are lifted onceagain by the piston 212 during the next stroke thereof. As described ingreater detail below, the outlet 214 of the supply pump 210 can be influid communication with the reservoir 220 such that the fluidpressurized by the supply pump 210 can be discharged into an internalcavity 221 defined in the reservoir 220.

In various embodiments, the reservoir 220 can include a bottom portion222, a housing 223, and a top portion 224, wherein, in at least oneembodiment, the outlet 214 of the supply pump 210 can be in fluidcommunication with the internal cavity 221 of the reservoir 220 througha port 228 the bottom portion 222, for example. In other variousembodiments, the supply pump 210 can be in fluid communication with thereservoir cavity 211 through a port in the housing 223 and/or the topportion 224, for example. In any event, the bottom portion 222 and thetop portion 224 can be sealingly engaged with the housing 223 wherein,in at least one embodiment, the bottom portion 222 and the top portion224 can be configured to engage the housing 223 in a snap-fit and/orpress-fit arrangement, for example. In various embodiments, the bottomportion 222 and the top portion 224 can be comprised of a plasticmaterial which may not degraded by the fluid contained within thereservoir 220, for example. In certain embodiments, the reservoir 220can further include a seal, such as an O-ring 229, for example, whichcan be positioned intermediate the bottom portion 222 and the housing223 and a seal, such as an O-ring 229, for example, positionedintermediate the housing 223 and the top portion 224 which can preventfluids from leaking out of the reservoir 220. In various embodiments,the housing 223 can be comprised of any suitable material, such asglass, for example. In at least one embodiment, the housing 223 can becomprised of borosilicate, for example, which may not be degraded by thefluid contained within the reservoir 220.

As discussed above, the supply pump 210 can be configured to supply afixed quantity of fluid to the internal reservoir cavity 221 for eachstroke of the supply pump piston 212. In use, the supply pump 210 can beoperated a suitable number of times, or cycles, in order to fill theinternal cavity 221 and/or fill the internal cavity 221 above apredetermined level, or height, within the internal cavity 221. Incertain embodiments, the reservoir 220 can include an overflow line 227which can be configured to vent fluid back to the fluid source, forexample, in the event that the reservoir 220 is overfilled. In variousembodiments, referring again to FIG. 14, the internal cavity 221 canhave a bottom 225, a top 226, and a height defined between the bottom225 and the top 226. In at least one such embodiment, the internalcavity 221 can be cylindrical and can have a constant circumferencealong the height thereof while, in other embodiments, the internalcavity 221 can have any suitable configuration. In various embodiments,as a result of the above, each cycle of the supply pump 210 can raisethe height of the fluid within the internal reservoir cavity 221 acertain, or fixed, amount. In at least one embodiment, the amount offluid in the reservoir 220 can be maintained by operating the supplypump 210 the same number of strokes that the dispensing pump 230 hasbeen operated, for example. In certain embodiments, the reservoir 210can comprise a sensor, such as level sensor 240, for example, which canbe configured to detect the height of the fluid within the reservoircavity 221 and/or changes in the height of the fluid within thereservoir cavity 221, as described in greater detail below.

In various embodiments, further to the above, the level sensor 240 cancomprise an analog sensor and can be mounted to the reservoir housing223. In at least one embodiment, the housing 223 can be comprised ofglass and the level sensor 240 can be attached to the glass using atleast one adhesive, for example. In at least one such embodiment, thelevel sensor can comprise a capacitive sensor, such as a linearcapacitive sensor, for example, which can have a first end 241positioned at or adjacent to the bottom 225 of the reservoir cavity 221and a second end 242 positioned at or adjacent to the top 226 of thereservoir cavity 221. In such embodiments, the level sensor 240 can beconfigured to generate a first, or low, voltage when the internal cavity211 is empty, or at least substantially empty, and a second, or high,voltage when the internal cavity 211 is full, or at least substantiallyfull. In addition, the level sensor 240 can be configured to generate arange of voltages between the low voltage and the high voltage,depending on the level of the fluid within the reservoir cavity 211.More particularly, in various embodiments, the voltage generated by thelevel sensor 240 can be a function of the fluid height within thereservoir cavity 221 and, thus, the voltage can increase as the fluidheight increases. In at least one such embodiment, the voltage can belinearly proportional to the fluid height, for example, wherein, in atleast one embodiment, the low voltage can be approximately zero voltsand the high voltage can be approximately five volts, for example.

In various embodiments, the fluid dispensing subsystem 200 a can furthercomprise a dispensing pump 230 which can be in fluid communication withthe internal cavity 211 of the reservoir 210 and can be configured todraw the fluid from the reservoir cavity 211 and dispense the fluid intothe fluid circulation system, and/or a mixing chamber within the fluidcirculation system, of the endoscope reprocessor 100. In at least oneembodiment, the inlet to the dispensing pump 230 can be in fluidcommunication with the bottom 225 of the internal chamber 221 through aport 238 in the bottom portion 222 of the reservoir 220. In certainembodiments, the dispensing pump 230 can comprise a positivedisplacement pump which can be configured to displace a fixed volume offluid per stroke. A positive displacement pump is described in detail inconnection with the supply pump 210 and such discussion is not repeatedherein for the sake of brevity. In some embodiments, the supply pump 210and the dispensing pump 230 can be identical, or at least nearlyidentical. In at least one embodiment, the dispensing pump 230 can beconfigured to displace the same, or at least substantially the same,amount of volume, or fluid, per stroke as the supply pump 210.

In use, the supply pump 210 can be operated to fill the internal chamber221 of the reservoir 220 until the fluid level has met or exceeded apredetermined height within the chamber 221. In various embodiments, thefluid dispensing subsystem 200 a can comprise a computer, ormicroprocessor, such as PCB assembly 250, for example, which can in bein electrical and/or signal communication with the supply pump 210, thedispensing pump 230, and/or the level sensor 240. In at least one suchembodiment, the PCB assembly 250 can be configured to detect the voltagepotential generated by the level sensor 240 and calculate the fluidheight within the reservoir 220 as a function of the voltage potential.In the event that the PCB assembly 250 calculates that the fluid levelwithin the reservoir 220 is below the predetermined height, the PCBassembly 250 can operate the fluid supply pump 210 until the fluid levelhas met or exceeded the predetermined height. In at least oneembodiment, the PCB assembly 250 may not operate the dispensing pump 230when the fluid level in the reservoir 220 is below the predeterminedheight. In the event that the PCB assembly 250 calculates that the fluidlevel in the reservoir 220 is at or above the predetermined height, thePCB assembly 250 can operate the dispensing pump 230 to supply the fluidcirculation system with the fluid, when needed. In certain embodiments,the PCB assembly 250 can be configured to operate the supply pump 210 inadvance of operating the dispensing pump 230 such that a sufficientsupply of fluid exists in the reservoir 220 before the dispensing pump230 is operated. In at least one embodiment, the PCB assembly 250 can beconfigured to operate the supply pump 210 after operating the dispensingpump 230 in order to replenish the supply of fluid within the reservoir220. In various embodiments, the PCB assembly 250 can be configured tooperate the dispensing pump 230 and the supply pump 210 simultaneouslysuch that the fluid in the reservoir 220 can be replenished as it isbeing dispensed by the dispensing pump 230.

As outlined above, the supply pump 210 can comprise a positivedisplacement pump and, in such embodiments, the PCB assembly 250 can beconfigured to monitor whether the supply pump 210 is delivering acorrect amount of fluid to the reservoir 220 per stroke of the pumppiston 212. More specifically, information regarding the fixedvolumetric displacement of the supply pump 210 can be programmed withinthe PCB assembly 250 such that the PCB assembly 250 can evaluate whetherthe increase in fluid volume within the reservoir 220 per stroke of thesupply pump 210, as measured by the fluid level sensor 240, matches thevolumetric displacement of the supply pump 210. In the event that theincrease in fluid within the reservoir 220 per stroke of the supply pump210, as measured by the fluid level sensor 240, is equal, or at leastsufficiently equal, to the fixed volumetric displacement of the supplypump 210, the PCB assembly 250 may signal to the operator of theendoscope reprocessor 100 that the supply pump 210 is being sufficientlysupplied with fluid from the fluid source. In the event that theincrease in fluid within the reservoir 220 per stroke of the supply pump210, as measured by the fluid level sensor 240, is not equal, or atleast sufficiently equal, to the fixed volumetric displacement of thesupply pump 210, the PCB assembly 250 may signal to the operator of theendoscope reprocessor 100 that the supply pump 210 is not beingsufficiently supplied with fluid from the fluid source and that thefluid source may need to be examined as the fluid source may be empty,for example. In various circumstances, examining the fluid source mayinclude replacing or replenishing the fluid source. In variousembodiments, the reservoir 220 can contain a quantity of fluid thereinwhich can be sufficient to supply the endoscope reprocessor 100, asneeded, while the operator examines the fluid supply. In previousendoscope reprocessors, the fluid circulation systems thereof drew fluiddirectly from the fluid supply and, thus, the endoscope reprocessorcould not identify that the fluid source had been depleted until anoperating cycle had already begun and the lack of fluid had interruptedthe operating cycle.

In various embodiments, further to the above, the endoscope reprocessor100 can comprise two basins 110, for example, which can each beconfigured such that an endoscope can be cleaned, disinfected, and/orsterilized therein. In certain embodiments, referring again to FIG. 16,the endoscope reprocessor 100 can comprise a separate fluid circulationsystem, such as circulation systems 290 a and 290 b, for example, forsupplying fluid to each basin 110. In such embodiments, the fluiddispensing subsystem 200 a can be configured to supply both of the fluidcirculation systems 290 a, 290 b with fluid from fluid source 201 a and,similarly, the fluid dispensing subsystem 200 b can be configured tosupply both of the fluid circulation systems 290 a, 290 b with fluidfrom fluid source 201 b. In at least one such embodiment, the endoscopereprocessor 100 can comprise a valve 280 a which can be, one, in fluidcommunication with the dispensing pump 230 of the fluid dispensingsubsystem 200 a and, two, in selective fluid communication with fluidcirculation systems 290 a, 290 b such that a fluid can be selectivelysupplied to the fluid circulation systems 290 a, 290 b from the fluidsource 201 a. Similarly, the endoscope reprocessor 100 can comprise avalve 280 b which can be, one, in fluid communication with thedispensing pump 230 of the fluid dispensing subsystem 200 b and, two, inselective fluid communication with fluid circulation systems 290 a, 290b such that a fluid can be selectively supplied to the fluid circulationsystems 290 a, 290 b from the fluid source 201 b. Prior to running anoperating cycle of a fluid circulation system, in certain embodiments,the fluid circulation system may require a quantity of the fluid, suchas a detergent and/or sterilant, for example, from the fluid dispensingsubsystem 200 a. In such embodiments, further to the above, the PCBassembly 250 can be programmed to maintain a quantity of fluid withinthe reservoir 220 of the subsystem 200 a such that, when fluid is neededto supply a fluid circulation system 290 a, 290 b, the fluid isavailable without having to operate the supply pump 210. In variouscircumstances, the quantity of fluid needed from a reservoir 220 by thefluid circulation system can be larger than the volume of fluid that canbe supplied by a single stroke of the dispensing pump 230 and, thus,multiple strokes of the dispensing pump 230 may be required. In anyevent, the quantity of a particular fluid needed by a fluid circulationsystem prior to an operating cycle of the instrument reprocessor 100 mayequal the minimum amount of fluid that the PCB assembly 250 may beprogrammed to maintain in a reservoir 220. In certain embodiments, thePCB assembly 250 may be programmed to maintain enough fluid in areservoir 220 to supply both of the fluid circulations systems with aparticular fluid to begin their operating cycles without needing to berefilled by the corresponding supply pump 210. Of course, further to theabove, the supply pump 210 could then be operated to refill thereservoir 220 after both of the fluid circulation systems have beensupplied with a sufficient quantity of fluid. In light of the above, invarious embodiments, a reservoir 220 may have enough fluid containedtherein to supply at least one operating cycle of a fluid circulationsystem prior to the corresponding supply pump 210 being activated torefill the reservoir 220 wherein, in the event that the supply pump 210is unable to refill the reservoir 220 due to an empty fluid supply, forexample, the operator of the endoscope reprocessor 100 is afforded anopportunity to replace the fluid supply prior to the next operatingcycle of a fluid circulation system.

Further to the above, the dispensing pump 230 can comprise a positivedisplacement pump and, in such embodiments, the PCB assembly 250 canmonitor whether the dispensing pump 230 is drawing a correct amount offluid per stroke from the reservoir 220. More specifically, informationregarding the fixed volumetric displacement of the dispensing pump 230can be programmed within the PCB assembly 250 such that the PCB assembly250 can evaluate whether the decrease in fluid within the reservoir 220per stroke of the dispensing pump 230, as measured by the fluid levelsensor 240, matches the fixed volumetric displacement of the dispensingpump 230. In the event that the decrease in fluid within the reservoir220 per stroke of the dispensing pump 210 is equal, or at leastsufficiently equal, to the fixed volumetric displacement of thedispensing pump 230, as measured by the fluid level sensor 240, the PCBassembly 250 may signal to the operator of the endoscope reprocessor 100that the dispensing pump 230 is being sufficiently supplied with fluidfrom the reservoir 220. In the event that the decrease in fluid withinthe reservoir 220 per stroke of the dispensing pump 230, as measured bythe fluid level sensor 240, is not equal, or at least sufficientlyequal, to the volumetric displacement of the dispensing pump 230, thePCB assembly 250 may signal to the operator of the endoscope reprocessor100 that the dispensing pump 230 is not being sufficiently supplied withfluid and that some examination and/or maintenance of the fluiddispensing subsystem may be required.

As discussed above with regard to various embodiments, each fluiddispensing subsystem 200 a, 200 b can comprise a fluid supply pump 210and a separate fluid dispensing pump 230. As also discussed above, invarious embodiments, the fluid supply pump 210 and the fluid dispensingpump 230 can be operated independently of one another to supply fluid toand dispense fluid from the reservoir 220, respectively. In certainalternative embodiments, a single pumping apparatus can be configuredto, one, pump fluid into the reservoir 220 from the fluid supply and,two, pump fluid from the reservoir 220 into a fluid circulation system.In at least one such embodiment, the pumping apparatus can comprise apiston having a first piston head positioned within a first cylinder anda second piston head positioned within a second cylinder wherein thepiston can be reciprocated linearly to move the first and second pistonheads within the first and second cylinders, respectively. In variousembodiments, the first cylinder can be in fluid communication with afluid source and the reservoir while the second cylinder can be in fluidcommunication with the reservoir and the fluid circulation system suchthat the first piston head moving within the first cylinder can pumpfluid from the fluid source into the reservoir and the second pistonhead moving within the second cylinder can pump fluid from the reservoirinto the fluid circulation system. In various embodiments, thearrangement of the first piston head and the first cylinder can comprisea first positive displacement pump and the arrangement of the secondpiston head and the second cylinder can comprise a second positivedisplacement pump. In certain embodiments, the pumping apparatus cancomprise a valve control system which can be configured to control orlimit the flow of fluid into the first cylinder and/or the secondcylinder, for example. In at least one such embodiment, the valvecontrol system can be configured to close a valve element and preventfluid from flowing into the second cylinder while fluid is being pumpedinto the reservoir from the first cylinder. Similarly, the valve controlsystem can be configured to close a valve element and prevent fluid fromflowing into the first cylinder while fluid is being pumped from thereservoir through the second cylinder. In such embodiments, the firstand second piston heads may be reciprocate within their respective firstand second cylinders; however, the flow of fluid through of thecylinders may be prevented, as described above. In various alternativeembodiments, a pump can comprise a rotary pump having a first aperturein fluid communication with the fluid source, a second aperture in fluidcommunication with the reservoir, and a third aperture in fluidcommunication with the fluid circulation system. In at least one suchembodiment, a valve control system can be configured to close or blockthe third aperture when pumping fluid into the reservoir and,alternatively, block the first aperture when pumping fluid from thereservoir. In certain embodiments, the valve control system couldinclude any suitable arrangement of one or more shuttle valves and/orspool valves, for example. In various embodiments, any suitable positivedisplacement pump including a three-way valve could be utilized to pumpfluid into the reservoir 220 from a fluid source and then from thereservoir 220 into the fluid circulation system.

As discussed above, referring again to FIG. 16, the endoscopereprocessor 100 can comprise a fluid dispensing system 200 which can beconfigured to supply a fluid to one or more fluid circulation systems.As also discussed above, the fluid dispensing system 200 can comprisemore than one fluid dispensing subsystem, such as first subsystem 200 aand second subsystem 200 b, for example. In various embodiments, thesecond subsystem 200 b can be identical, or at least substantiallyidentical, to the first subsystem 200 a and, as a result, the structureand operation of the second subsystem 200 b is not repeated herein forthe sake of brevity. In at least one embodiment, the first subsystem 200a can be configured to dispense a first fluid to one or more fluidcirculation systems, such as fluid circulation systems 290 a and 290 b,for example, and the second subsystem 200 b can be configured todispense a second fluid to the fluid circulation systems 290 a, 290 b,for example. In at least one such embodiment, the first fluid dispensingsubsystem 200 a can be configured to dispense a detergent, for example,to a fluid circulation system while the second fluid dispensingsubsystem 200 b can be configured to dispense a sterilant, such asperacetic acid, for example, to the fluid circulation system. As alsodiscussed above, the fluid dispensing systems 200 a and 200 b may beoperated at different times to supply the fluid circulation systems withtheir respective fluids at different times during the operating cyclesthereof. In various other circumstances, the fluid subsystems 200 a and200 b can be operated at the same time to supply the same fluidcirculation system with different fluids and/or at the same time tosupply different fluid circulation systems with different fluids, forexample.

Further to the above, the first fluid circulation system 290 a cancomprise a first channel flow subsystem 160 and a first pump 162 forcirculating a fluid through the first circulation system 290 a while thesecond fluid circulation system 290 b can comprise a second channel flowsubsystem 160 and a second pump 160 for circulating a fluid through thesecond circulation system 290 b. In various other embodiments, aninstrument reprocessor may comprise any suitable number of fluidcirculation systems; however, with regard to any one of the fluidcirculation systems, the channel flow subsystem 160 thereof can beconfigured to control an initialization, or start-up, procedure of thefluid circulation system. More specifically, after an instrument hasbeen placed in a basin 110 and the lid 130 has been closed, the operatorcan initialize an operating cycle to clean the instrument and, at suchpoint, the channel flow subsystem 160 can be configured to control theinitial flow of reprocessing fluid from the pump 162. In variousembodiments, the instrument, such as an endoscope, for example, cancomprise a plurality of channels, or lumens, extending therethroughwhich can have different lengths, diameters, and/or configurations, forexample, which can cause the channels to have different overall flowresistances, or restrictions, for example. In the event that pump 162were to be initialized with all of the proportional valves 174 in anopen condition and/or the same condition, the fluid flowing from thepump 162 would tend to fill and/or pressurize the channels of theendoscope having lower flow resistances before filling and/orpressurizing the endoscope channels having higher flow resistances, forexample. In various circumstances, such a situation would be transientand the desirable operating conditions or steady state operatingconditions of the fluid circulation system would eventually be reached.In some circumstances, this start-up procedure is entirely suitable. Inother circumstances, however, a different start-up procedure may bedesirable.

In various embodiments, further to the above, the channel flow subsystem160 can include a computer and/or a microprocessor, for example, whichcan arrange the valves 174 in different conditions during theinitialization procedure. In at least one embodiment, the subsystemcomputer can operate the valves 174 to compensate for the different flowresistances, or restrictions, of the endoscope channels, for example.For instance, for the valves 174 that control the flow of fluid throughthe high flow resistance endoscope channels, the subsystem computer canplace such valves 174 in a fully open condition while, for the valves174 that control the flow of fluid through the low fluid resistanceendoscope channels, the subsystem computer can place such valves 174 ina partially closed condition. In such embodiments, the flow of fluidfrom the pump 162 may tend to fill and/or pressurize all of theendoscope channels at the same time, or at least substantially the sametime. In certain circumstances, the transient state for filling thechannels with pressurized fluid may be shortened and a steady stateoperating condition, or a desirable operating condition, can be reachedin less time. Such embodiments may reduce the overall time needed to runa cleaning cycle of the instrument reprocessor 100. In embodimentshaving eight endoscope channels and eight flow control units 170 forcontrolling the flow of fluid through eight corresponding channel supplylines 164, for example, the eight proportional valves 174 thereof canall be placed in different conditions, and/or the same condition, ofbeing open, closed, partially open, and/or partially closed, forexample.

In various embodiments described herein, the flow subsystem computer canutilize one or more criteria, or parameters, for controlling the valves174 of the flow control units 170 during the initialization, orstart-up, procedure. Further to the above, a first proportional valve174 of a first control unit 170 can be configured to control the fluidflow through a first endoscope channel defined by a first value of aparticular parameter, a second proportional valve 174 of a secondcontrol unit 170 can be configured to control the fluid flow through asecond endoscope channel defined by a second value of the particularparameter, and a third proportional valve 174 of a third control unit170 can be configured to control the fluid flow through a thirdendoscope channel defined by a third value of a particular parameter. Invarious embodiments, the first value of the parameter can be larger thanthe second value of the parameter and the second value can be largerthan the third value of the parameter wherein the first valve 174 can bemodulated to a first open state, the second valve 174 can be modulatedto a second open state based on the difference between the first valueand the second value of the parameter, and the third valve 174 can bemodulated to a third open state based on the difference between thefirst value and the third value of the parameter in order to regulatethe flow of fluid through the first, second, and third channels. In atleast one such embodiment, the first open state, the second open state,and the third open state of the first, second, and third valves 174,respectively, can be selected such that, during the initialization, orstart-up, procedure of the fluid circulation system, the flow of fluidthrough the first, second, and third endoscope channels can be evenly,or at least substantially evenly distributed, across the first, second,and third endoscope channels. In at least one embodiment, the first,second, and third open states of the valves 174 can be selected suchthat the volumetric flow rates through the endoscope channels are equal,or at least substantially equal, to one another as the endoscopechannels fill with fluid. In such an embodiment, the fluid flow ratesthrough the endoscope channels can increase during the initializationprocedure wherein each fluid flow can increase concurrently with theother fluid flows. In at least one embodiment, the first, second, andthird open states of the valves 174 can be selected such that the gaugepressure of the fluid flowing through the endoscope channels are equal,or at least substantially equal, to one another as the endoscopechannels fill with fluid. In such an embodiment, the pressure or thefluid flowing through the endoscope channels can increase during theinitialization procedure wherein the pressure of each fluid flow canincrease concurrently with the pressure of the other fluid flows.

In at least one embodiment, further to the above, the parameter forselecting the open conditions of the proportional valves 174 cancomprise the flow resistance values of the instrument channels. Invarious circumstances, the flow resistance value of an instrumentchannel can be influenced by many variables; however, the flowresistance value of an instrument channel can be largely determined bythe channel length, the channel diameter, and the curves, or bends, inthe channel path. Instrument channels having longer lengths, smallerdiameters, and/or more curves in the channel path will typically havehigher flow resistance values than instrument channels having shorterlengths, larger diameters, and/or less curves in the channel path. Inany event, the instrument channel having the highest flow resistancevalue of the medical instrument can be selected as a baseline from whichthe fluid flows through the other instrument channels can be adjusted.In at least one embodiment, the first instrument channel can have thehighest fluid flow resistance and the first proportional valve 174 canbe set to a fully open condition, for example. In various embodiments,the second proportional valve 174 can be closed a certain amount basedon the difference between the first flow resistance value and the secondflow resistance value. Similarly, the third proportional valve 174 canbe closed a certain amount based on the difference between the firstflow resistance value and the third flow resistance value. In variouscircumstances, the larger the difference between the flow resistancevalue of an instrument channel and the first flow resistance value, or abaseline flow resistance value, the greater degree in which thecorresponding proportional valve 174 can be closed.

In any event, further to the above, once the steady state operatingcondition, or the desirable operating condition, of the fluidcirculation system has been reached, the subsystem computer can permitthe flow control units 170 to independently control and govern the flowof fluid through the endoscope channel supply lines 164 as discussedabove. In various circumstances, the devices and methods describedherein can be designed to provide an adequate supply of reprocessingfluid to clean, disinfect, and/or sterilize an endoscope, and/or anyother suitable instrument, comprising channels having different flowresistances. Further to the above, these devices and methods can beconfigured to supply an adequate supply of reprocessing fluid to thechannels by controlling the fluid flow through each channelindividually.

In various circumstances, the pump 162 can have a sufficient output tosupply all of the reprocessor supply lines 164 and the endoscopechannels associated therewith with an adequate supply of reprocessingfluid during the initialization of the operating cycle and throughoutthe operating cycle. Further to the above, the flow control units 170can be configured to manage the fluid supplied thereto such that eachreprocessor supply line 164 has a flow rate therethrough which meets orexceeds the minimum target flow rate and, thus, is not starved forfluid. In the event that the fluid flow through one or more of thereprocessor supply lines 164 is below the minimum target flow rate andthe pump 162 is not operating at maximum capacity, the output of thepump 162 can be increased. In some circumstances, the gauge pressure ofthe reprocessing fluid exiting the pump 162 can increase above thetarget gauge pressure, such as 35 psig, for example, at leasttemporarily in order for the pump 162 to meet the supply demands of thereprocessor supply lines 164 and the endoscope channels associatedtherewith. In the event that the fluid flow through one or more of thereprocessor supply lines 164 is below the minimum target flow rate andthe pump 162 is operating at a maximum, or near maximum, capacity, atleast one booster pump could be operated to increase the flow rateand/or pressure of the reprocessing fluid entering into the manifold 166and the reprocessor supply lines 164. In various embodiments, the atleast one booster pump could be in series with pump 162 and/or inparallel with the pump 162, for example, wherein the at least onebooster pump could be selectively operated to assist the pump 162.

In various embodiments discussed herein, each reprocessor supply line164 of the channel flow subsystem 160 can comprise a proportional valve174 configured to control a variable orifice. In various otherembodiments, at least one of the reprocessor supply lines 164 caninclude a fixed orifice or a fixed orifice valve. In at least oneembodiment, the fixed orifice valve can be positionable in either anopen condition or a closed condition. In at least one such embodiment,the reprocessor supply line 164 having a fixed orifice valve can becoupled to the endoscope channel having the highest fluid flowresistance, for example, wherein the fluid flow rate through such aendoscope channel may be a function of the gauge pressure of thereprocessing fluid supplied by the pump 162. In various embodiments, thereprocessor supply lines 164 having a variable orifice controlled by aproportional valve 174, for example, can be modulated with respect tothe reprocessor supply line 164 having a fixed orifice valve when thefixed orifice valve is in an open condition, for example.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdo not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this invention pertains.

What is claimed is:
 1. A method of utilizing a monitoring system formaintaining a volume of reprocessing fluid within a supply reservoir fora fluid circulation system of an instrument reprocessor, comprising:supplying a quantity of reprocessing fluid to the supply reservoir froma reprocessing fluid source; sensing the quantity of reprocessing fluidin the supply reservoir; determining whether the quantity ofreprocessing fluid in the supply reservoir is more than a predeterminedamount; operating a positive-displacement filling pump to supplyreprocessing fluid to the supply reservoir if the quantity ofreprocessing fluid in the supply reservoir is less than thepredetermined amount, wherein the positive-displacement filling pump isconfigured to supply a fixed volume of reprocessing fluid per stroke;monitoring the quantity of reprocessing fluid in the supply reservoir asthe positive-displacement filling pump is being operated; determiningwhether the quantity of reprocessing fluid in the supply reservoir hasincreased by a re-supply volume equal to the product of the volumedisplaced per stroke and the number of strokes of thepositive-displacement filling pump; and broadcasting an alert if thequantity of reprocessing fluid in the supply reservoir has not increasedby the re-supply volume.
 2. The method of claim 1, further comprising:operating a positive-displacement dispensing pump to deliver thereprocessing fluid to the fluid circulation system if the quantity ofreprocessing fluid in the supply reservoir is equal to or more than thepredetermined amount; and detecting a change in the quantity ofreprocessing fluid in the supply reservoir after reprocessing fluid hasbeen dispensed from the supply reservoir.
 3. The method of claim 2,wherein the positive-displacement dispensing pump is the same pump asthe positive-displacement filling pump.
 4. The method of claim 2,further comprising replacing the reprocessing fluid source in responseto the broadcasted alert, wherein the replacing the reprocessing fluidsource in response to the broadcasted alert can occur at the same timethat the positive-displacement dispensing pump delivers the reprocessingfluid to the fluid circulation system.
 5. The method of claim 2, whereinthe positive-displacement dispensing pump is configured to dispense afixed volume of reprocessing fluid per stroke to the fluid circulationsystem which is equal to the fixed volume of reprocessing fluid perstroke supplied by the positive-displacement filling pump.
 6. The methodof claim 2, wherein the positive-displacement dispensing pump can beoperated at the same time as the positive-displacement filling pump. 7.The method of claim 1, further comprising operating thepositive-displacement filling pump to dispense reprocessing fluid fromthe supply reservoir to the fluid circulation system if the quantity ofreprocessing fluid in the supply reservoir is equal to or more than thepredetermined amount, wherein the positive-displacement filling pump isconfigured to dispense a fixed volume of reprocessing fluid per stroke.8. The method of claim 1, wherein the reprocessing fluid is selectedfrom the group consisting of a detergent, a sterilant, a disinfectant,water, air, and an alcohol.
 9. A method of utilizing a monitoring systemfor maintaining a volume of fluid within a supply reservoir, comprising:operating a pump to supply fluid to the supply reservoir; monitoring aquantity of fluid in the supply reservoir as the pump is being operated;determining whether the quantity of fluid in the supply reservoir hasincreased by a re-supply volume equal to a product of a volume displacedper stroke and a number of strokes of the pump; and broadcasting analert if the quantity of fluid in the supply reservoir has not increasedby the re-supply volume.
 10. The method of claim 9, wherein the fluid isselected from the group consisting of a detergent, a sterilant, adisinfectant, water, air, and an alcohol.
 11. The method of claim 9,wherein operating the pump to supply fluid to the supply reservoirfurther comprises: flowing the fluid through a first fluid channelcomprising a first valve and a first pressure differential sensor;detecting a first pressure differential in the fluid flowing into thefirst valve utilizing the first pressure differential sensor; andmodulating the first valve to control the first flow rate of the fluidthrough the first fluid channel utilizing an output from the firstpressure differential sensor.
 12. The method of claim 9, wherein thevolume displaced per stroke is a value programmed in a printed circuitboard (PCB) assembly and the number of strokes of the pump is determinedby the PCB assembly during the operating of the pump to supply fluid tothe supply reservoir.
 13. A method of utilizing a monitoring system formaintaining a volume of fluid within a supply reservoir, comprising:supplying a quantity of fluid to the supply reservoir from a fluidsource; sensing the quantity of fluid in the supply reservoir;determining whether the quantity of fluid in the supply reservoir ismore than a predetermined amount; operating a pump to supply fluid tothe supply reservoir if the quantity of fluid in the supply reservoir isless than the predetermined amount, wherein operating the pump to supplyfluid to the supply reservoir, further comprising: flowing the fluidthrough a first fluid channel comprising a first valve and a firstpressure differential sensor; detecting a first pressure differential inthe fluid flowing into the first valve utilizing the first pressuredifferential sensor; and modulating the first valve to control the firstflow rate of the fluid through the first fluid channel utilizing anoutput from the first pressure differential sensor monitoring thequantity of fluid in the supply reservoir as the pump is being operated;determining whether the quantity of fluid in the supply reservoir hasincreased by a re-supply volume; and broadcasting an alert if thequantity of fluid in the supply reservoir has not increased by there-supply volume.